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Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients

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ClinicalTrials.gov Identifier: NCT00454922
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Glaucoma is a leading cause of blindness worldwide. Non-adherence to glaucoma medication, which may result in loss of vision, is known to be prevalent. Available information regarding adherence to prescribed medical therapy suggests that some apparent treatment failures may actually be due to non-adherence. The investigators' specific aim is to conduct a study that will examine the effect of a glaucoma educator intervention on adherence to topical glaucoma therapy. The investigators' hypothesis is that patient education and counseling delivered by a trained glaucoma educator, through both planned visits and telephone contacts, will increase adherence to topical glaucoma therapy.

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: standard of care Other: education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Glaucoma Educators on Adherence to Prescribed Therapeutic Regimens in Glaucoma Patients
Study Start Date : October 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: 1
education
Other: education
meet with trained glaucoma educator 6 times over life of study

Placebo Comparator: 2
standard of care
Behavioral: standard of care
no intervention




Primary Outcome Measures :
  1. primary outcome is adherence. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. differences between patients randomized to standard of care and education intervention. [ Time Frame: 6 months ]
  2. differences between dropouts and non-dropouts. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary or secondary open angle glaucoma.
  • Currently on monotherapy drop treatment for glaucoma.
  • Age > 18 years.
  • Patient has presented for care at the Rocky Mountain Lions Eye Institute Glaucoma Center.

Exclusion Criteria:

  • Inability to independently administer eye drops due to physical disability as reported by the patient.
  • Cognitive impairment that would interfere with the ability to self-administer medications as evidenced by a TICS score < 16.
  • Patients who demonstrate > 80% adherence to glaucoma treatment during the 30 day run-in period.
  • It is anticipated that the patient will require glaucoma surgery within the next six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454922


Locations
United States, Colorado
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Malik Y. Kahook, MD Rocky Mountain Lions Eye Institute

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00454922     History of Changes
Other Study ID Numbers: 07-0106
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: October 2008

Keywords provided by University of Colorado, Denver:
glaucoma
patient educator

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases